Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Status: Enrolling

Conditions: Head and Neck Neoplasms

Treatments: Other: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05418842

F4T

Details and patient eligibility

About

The main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. The length of intervention will be at least 2 weeks. Data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following CRT. Primary outcome is functional capacity as assessed by the six-minute walk test. Additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old;
• Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
• Proposed for concomitant chemoradiotherapy with curative intent;
• Date of treatment beginning ≥2 weeks from baseline assessment;
• ECOG-Performance Status 0-1.

Exclusion criteria

• Completion of previous anticancer treatment within less than a year;
• Uncontrolled hypertension, cardiac or pulmonary disease;
• Contraindications to exercise training;
• Inability to provide informed consent;
• Expected inability to fulfil the proposed schedule.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Prehabilitation Group

Experimental group

Description:

In addition to standard medical care, the prehabilitation group will have three supervised exercise training sessions per week from diagnosis to start of radiotherapy (pre-treatment phase).

Treatment:

Other: Prehabilitation

Control Group

No Intervention group

Description:

The control group will receive the standard medical care.